← Product Code [FZD](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD) · K844960

# CANAL WALL PROSTHESIS (K844960)

_Richards Medical Co., Inc. · FZD · Feb 26, 1985 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K844960

## Device Facts

- **Applicant:** Richards Medical Co., Inc.
- **Product Code:** [FZD](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD.md)
- **Decision Date:** Feb 26, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3590
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K844960](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K844960)

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